Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program

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Published

September 17, 2021

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Agency's Biosimilars User Fee Program.

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<title>Federal Register, Volume 86 Issue 178 (Friday, September 17, 2021)</title>
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[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Notices]
[Pages 51900-51902]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20060]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1967]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Biosimilars User Fee Program

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with the
Agency's Biosimilars User Fee Program.

DATES: Submit either electronic or written comments on the collection
of information by November 16, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 16, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 16, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-1967 for ``Biosimilars User Fee Program.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#cf9f9d8e9cbbaea9a98fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="752527342601141313351311145b1d1d065b121a03">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice

[[Page 51901]]

of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Biosimilars User Fee Program

OMB Control Number 0910-0718--Revision

This information collection supports FDA's Biosimilars User Fee
Program. The Biologics Price Competition and Innovation Act of 2009
(BPCI Act) amended the Public Health Service Act (PHS Act) to create an
abbreviated approval pathway for biological products shown to be
biosimilar to or interchangeable with an FDA-licensed reference
biological product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)),
added by the BPCI Act, allows a company to apply for licensure of a
biosimilar or interchangeable biological product (351(k) application).
The BPCI Act also amended section 735 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications as a type
of application under ``human drug application'' for the purposes of the
prescription drug user fee provisions.
The Biosimilar User Fee Act of 2012 (BsUFA) authorizes FDA to
assess and collect user fees for certain activities in connection with
biosimilar biological product development (BPD). BsUFA was reauthorized
for an additional 5 years in August 2017 (BsUFA II). We developed the
guidance entitled ``Assessing User Fees Under the Biosimilar User Fee
Amendments of 2017'' to assist industry in understanding when fees are
incurred and the process by which applicants can submit payments. The
guidance also explains how respondents can request discontinuation from
the BPD program as well as how respondents can request to move products
to the discontinued section of the biosimilar list. Finally, the
guidance provides information on the consequences of failing to pay
BsUFA II fees as well as processes for submitting reconsideration and
appeal requests. The guidance is available on the FDA website at:
<a href="https://www.fda.gov/media/134567/download">https://www.fda.gov/media/134567/download</a>. The guidance was issued
consistent with our Good Guidance Practice regulations in Sec. 10.115
(21 CFR 10.115), which provide for public comment at any time.
We also developed Form FDA 3792, the Biosimilars User Fee Cover
Sheet, which is submitted by each new BPD entrant (identified via a new
meeting request or investigational new drug (IND) submission) and for
new biologics license applications (BLAs). Form FDA 3792 requests the
minimum necessary information to identify the request, to determine the
amount of the fee to be assessed, and to account for and track user
fees. The form provides a cross-reference of the fees submitted for an
activity with the actual submission or activity by using a unique
number tracking system. The information collected is used by FDA's
Center for Drug Evaluation and Research and Center for Biologics
Evaluation and Research to initiate the administrative screening of
biosimilar biological product INDs and BLAs and to account for and
track user fees associated with BPD meetings.
In addition to Form FDA 3792, the information collection includes
an annual survey of all BsUFA II participants designed to provide
information to FDA of anticipated BsUFA II activity in the upcoming
fiscal year. This information helps FDA set appropriate annual BsUFA II
fees.
For efficiency of Agency operations, we are consolidating related
information collection currently approved in OMB control number 0910-
0719. Specifically we are including our current commitment goals as set
forth in the document ``BsUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2018 Through 2022,'' which represents the
product of FDA discussions with regulated industry and public
stakeholders, as mandated by Congress. The document, referred to as the
``BsUFA II letter,'' is available on our website at: <a href="https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf">https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf</a>. The performance and procedural goals specified in the
BsUFA II letter apply to aspects of the biosimilar biological product
review program that are important for facilitating timely access to
safe and effective biosimilar medicines for patients. Among those
considerations is providing feedback to requests from regulated
industry. Each year, FDA review staff participate in many meetings with
requesters who seek advice relating to the development and review of a
biosimilar or interchangeable product. Because these meetings often
represent critical points in the regulatory and development process, it
is important that there are clear procedures for the timely and
effective conduct of such meeting. Accordingly, we issued draft
guidance, ``Formal Meetings Between the FDA and Sponsors or Applicants
of BsUFA Products,'' available on our website at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry</a>. The guidance was issued consistent with Section I, Part 6 of
the BsUFA II letter (see p. 25), and with our Good Guidance practice
regulations in Sec. 10.115, which provide for public comment at any
time. The guidance provides procedural instruction helpful to
respondents and helps us reach what we believe is a more accurate
burden estimate for the information collection.
Also available from our website is our Biosimilars Action Plan
(BAP), which discusses key actions the Agency is taking to encourage
innovation and competition among biologics and the development of
biosimilars. The BAP builds on progress in implementing the approval
pathway for biosimilar and interchangeable products, and provides
interested persons with updates and resource material.
We estimate the burden of this collection of information as
follows:

[[Page 51902]]

Table 1--Estimated Annual Reporting Burden
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Number of
FDA form; survey Number of responses per Total annual Average burden per Total hours
respondents respondent responses response (hours)
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Biosimilar User Fee Cover 60 1 60 0.5 (30 minutes).. 30
Sheet (Form FDA 3792).
Annual Survey............... 60 1 60 1................. 60
Request for discontinuation 10 1 10 1................. 10
from BPD program.
Request to move products to 5 1 5 0.5 (30 minutes).. 2.5
discontinued section of the
Biosimilar List.
Biosimilar product 4 2.25 9 860............... 7,740
applications (351(k)(2)(A)).
Interchangeable product 2 1 2 860............... 1,720
applications (351(k)(2)(B).
Patent infringement 4 2.25 9 2................. 18
notifications.
Formal Meetings GFI 69 2.30 159 21.42............. 3,405
Recommendations.
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Total................... .............. .............. 314 .................. 12,985.5
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In anticipation of increased participation in the BPD program, we
have increased our estimate to reflect an increase in the number of
respondents since last OMB review. We have also made adjustments to
reflect information collection consolidated from OMB control number
0910-0719. We invite comment on our estimates and assumptions.

Dated: September 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20060 Filed 9-16-21; 8:45 am]
BILLING CODE 4164-01-P

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